A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

  • Idiopathic Pulmonary Fibrosis
Trial Status:

Completed

This trial runs in
Countries
  • Germany
  • United States
Trial Identifier:

NCT02648048 2015-003481-81 GB29764

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02648048 , GB29764 , 2015-003481-81 Trial Identifier
      Pirfenidone, Vismodegib Treatments
      Idiopathic Pulmonary Fibrosis Condition
      Official Title

      A Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

      Eligibility Criteria

      All Gender
      ≥ 40 Years & ≤ 80 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
      • Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks required prior to and during screening
      • Greater than or equal to (>=) 50 percent (%) and less than or equal to (<=) 100% of predicted forced vital capacity (FVC) at screening
      • Stable baseline lung function as evidenced by a difference of less than (<) 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to enrollment
      • >=30% and <=90% of predicted diffusion capacity of the lung for carbon monoxide at screening
      • Agree to use protocol defined methods of contraception
      • Male participants must agree not to donate semen during the study and for at least 2 months (or as per local requirements) after the last dose of vismodegib
      • Agree not to donate blood or blood products during the study and for at least 9 months (or as per local requirements) after the last dose of study treatment
      Exclusion Criteria
      • Prior treatment with vismodegib or any Hh-pathway inhibitor
      • Evidence of other known causes of interstitial lung disease
      • Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
      • Lung transplant expected within 6 months of screening
      • Evidence of clinically significant lung disease other than IPF
      • Post-bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening
      • Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <6 months, likely to require a change in therapy during the study
      • Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
      • Known current malignancy or current evaluation for a potential malignancy
      • Known immunodeficiency, including, but not limited to, human immunodeficiency virus infection
      • Evidence of acute or chronic hepatitis or known liver cirrhosis
      • Creatinine clearance <=30 milliliter per minute, calculated using the Cockcroft-Gault formula

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